Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Recruitment status was Recruiting
Acute Myeloid Leukemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia|
- Incidence of Invasive fungal infections [ Time Frame: 30th day after the end of first line chemotherapy ] [ Designated as safety issue: No ]To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
|Study Start Date:||January 2010|
Newly disgnosed AML
Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.
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EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA
In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003, (Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and mortality in patients treated with conventional chemotherapies, particularly in those suffering from acute myeloid leukemia (AML).
In general, the major factors that have been recognized as influencing the likelihood of invasive fungal infection are the patient's immune status, the degree of any organ damage (e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and prior infection). Since the 1990s, different risk-stratification strategies have been evaluated in order to identify those patients who may benefit from intensive prophylactic and diagnostic measures. However, despite having similar risk profiles, only a subset of AML patients will develop an IFI. One of the most exciting recent advances in the understanding of the epidemiology of IFIs is the recognition of the complexity of the host and the identification of new host-related risk factors.
Aim of this study is to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors.
Aims and objective:
- To identify high risk subjects that can take advantage of an antifungal prophylaxis or an early antifungal treatment (preemptive treatment).
- To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
- To analyze hospital-related sources of fungal infection, from well known predisposing factors (i.e. duration and severity of neutropenia) to other like central venous catheter, urinary catheter, comorbidities, etc.
- To analyze the impact of both the prophylactic regimen adopted and the antifungal treatment.
- Prospective, multicenter, observational and clinical-epidemiological study.
- The study is expected to enroll at least 500 patients with newly diagnosed acute myeloid leukemia, those eligible for treatment and those not eligible, within 2 years or until the achievement of a statistically evaluable number of cases.
- SEIFEM 2010 is a noninterventional registry and therefore there will not be any any change physicians' diagnostic and therapeutic choices, that remain related to local guidelines.
- Every patient who accept to take part to the study, will be asked to read and sign an informed consent.
- An apposite form, with a detailed epidemiological section, should be compiled by clinicians for each enrolled patient.
- A complete information page on the study is supplied to each patient enrolled.
In the questionnaire, possible risk factors for invasive fungal infections, prior to the onset of acute leukemia, are evaluated. The module consists of several sections:
- Personal information (age, sex, observation time of the case, AML subtype, performance status at admission), patient data will be anonymous.
- Comorbidities (diabetes, chronic renal failure, COPD, chronic liver disease, previous TBC)
- A section compiled by the patient about possible risk factors related to the daily living habits (location and type of residence, profession, hobbies, pets, personal hygiene, ambiental exposures, consume of tobacco, alcohol or illicit drugs and others)
- A second part of the form will be compiled at the time of evaluation after induction chemotherapy (between 30 and 40 days after chemotherapy) or, for those not suitable for conventional treatment, 30-40 days after diagnosis.
At the time of a diagnosis of fungal infection data on the type of infection, treatment and course of infection will be evaluated.
Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a noninterventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.
Forty-three Italian divisions of Hematology will take part to the study, distributed among universities and highly specialized hospitals located throughout the country.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315925
|University of Ancona||Recruiting|
|Ancona, AN, Italy|
|Contact: Massimo Offidani, MD email@example.com|
|Principal Investigator: Massimo Offidani, MD|
|University of Bary||Recruiting|
|Bari, BA, Italy|
|Contact: Mario Delia, MD firstname.lastname@example.org|
|Principal Investigator: Giorgina Specchia|
|Sub-Investigator: Mario Delia|
|University of Bologna||Recruiting|
|Bologna, BO, Italy|
|Contact: Nicola Vianelli email@example.com|
|Principal Investigator: Nicola Vianelli|
|University of Firenze||Recruiting|
|Firenze, FI, Italy|
|Contact: Rosa Fanci, MD firstname.lastname@example.org|
|Principal Investigator: Rosa Fanci|
|Tricase, LE, Italy|
|Contact: Vincenzo Pavone email@example.com|
|Milano, MI, Italy|
|Contact: Annamaria Nosari, MD firstname.lastname@example.org|
|Principal Investigator: Annamaria Nosari, MD|
|Rome, RM, Italy, 00168|
|Contact: Livio Pagano, MD +390630154180 email@example.com|
|Principal Investigator: Livio Pagano, MD|
|Sub-Investigator: Morena Caira, MD|
|Sub-Investigator: Mario Mancinelli, MD|
|IFO||Active, not recruiting|
|Rome, RM, Italy|
|Rome, RM, Italy|
|Contact: Maria Grazia Garzia firstname.lastname@example.org|
|Rome, RM, Italy|
|Contact: Anna Chierichini email@example.com|
|University of Tor Vergata||Recruiting|
|Rome, RM, Italy|
|Contact: Adriano Venditti firstname.lastname@example.org|
|Le Molinette Hospital||Recruiting|
|Torino, TO, Italy|
|Contact: Alessandro Busca email@example.com|
|Hospital of Brescia||Recruiting|
|Contact: Chiara Cattaneo, MD firstname.lastname@example.org|
|Sub-Investigator: Chiara Cattaneo|
|Principal Investigator: Giuseppe Rossi|
|University of Cagliari||Recruiting|
|Contact: Adriana Vacca email@example.com|
|Contact: Cristina Gasbarrino firstname.lastname@example.org|
|Principal Investigator: Sergio Storti|
|Cuneo Hospital||Active, not recruiting|
|Contact: Desiree Caselli email@example.com|
|Contact: Elio Castagnola firstname.lastname@example.org|
|La Spezia Hospital||Recruiting|
|La Spezia, Italy|
|Contact: Annunziata Manna email@example.com|
|Contact: De Paolis firstname.lastname@example.org|
|Lecce Pediatric Hospital||Active, not recruiting|
|University of Modena e Reggio||Recruiting|
|Contact: Mario Luppi email@example.com|
|Principal Investigator: Mario Luppi|
|Contact: Luisa Verga firstname.lastname@example.org|
|San Gerardo Hospital||Active, not recruiting|
|"Federico II" University||Recruiting|
|Contact: Marco Picardi, MD email@example.com|
|Cardarelli Hospital||Active, not recruiting|
|Pausilion Hospital||Active, not recruiting|
|University of Palermo||Recruiting|
|Contact: Maria Enza Mitra firstname.lastname@example.org|
|Principal Investigator: Maria Enza Mitra|
|University of Parma||Recruiting|
|Contact: Cecilia Caramatti email@example.com|
|S.Matteo Hospital, Department of Hematology||Recruiting|
|Contact: Carlo Castagnola firstname.lastname@example.org|
|Principal Investigator: Carlo Castagnola|
|S.Matteo Hospital, Department of Medicine||Recruiting|
|Contact: Rosangela Invernizzi email@example.com|
|University of Perugia, Pediatric Hematology||Recruiting|
|Contact: Franco Aversa firstname.lastname@example.org|
|University of Perugia||Recruiting|
|Contact: Franco Aversa email@example.com|
|Principal Investigator: Franco Aversa|
|Contact: Prassede Salutari firstname.lastname@example.org|
|Reggio Calabria Hospital||Recruiting|
|Reggio Calabria, Italy|
|Contact: Bruno Martino email@example.com|
|Reggio Emilia Hospital||Recruiting|
|Reggio Emilia, Italy|
|Contact: Alessandro Bonini Alessandro.Bonini@asmn.re.it|
|"Padre Pio" Hospital||Recruiting|
|San Giovanni Rotondo, Italy|
|Contact: Lorella Melillo firstname.lastname@example.org|
|Regina Margherita Hospital||Active, not recruiting|
|Contact: Mareva Giacchino email@example.com|
|University of Udine||Recruiting|
|Contact: Anna Candoni firstname.lastname@example.org|
|University of Verona||Recruiting|
|Contact: Gianpaolo Nadali email@example.com|
|Contact: Simone Cesaro firstname.lastname@example.org|